Now over 1 in 5 Thoracic Organ Transplants are preserved using Paragonix Advanced Organ Preservation and Tracking Technology

CAMBRIDGE, MASSACHUSETTS – August 17, 2022 – Paragonix Technologies, Inc. is announcing a major milestone of preserving over 2,000 donor organs, providing transplant centers Advanced Organ Preservation (AOPT) technology and a nationwide clinical support network. Each of these technologies utilize first-of-its-kind preservation methods and have proven to be a major advancement over the current ice and cooler practice still used today. Paragonix devices combine clinically-proven, stable, hypothermic preservation technology with an extensive clinical support network, supplemented by innovative digital tools for complete control over organ tracking, monitoring, and reporting.¹

“We are humbled and grateful to be part of transplant patients’ path to a new life while honoring the selfless gift of donor patients with our technology. Our portfolio of advanced organ preservation and tracking systems provides a safe and effective way for donor organs to be preserved, tracked, and transported to their destination,” said Dr. Lisa Anderson, CEO of Paragonix.

To mark this clinical milestone of over 2,000 donor organs being preserved, transported, and tracked using Paragonix devices, Paragonix is sharing some key contributions of its technology and the associated global clinical data and organ tracking efforts:

• Paragonix clinical research partners have enrolled over 1,400 patients in the past 3 years from 22 transplant centers (heart, lung, and liver) to the GUARDIAN Series of Clinical Registries, collecting over 187,000 clinical data points.
• Paragonix customers have downloaded over 1,200 data reports on donor organ procurements, providing detailed records of the organ preservation environment.
• The Paragonix app has provided an estimated 800,000 data points related to donor organ transports.
• The Paragonix team has provided in person support in over 800 donor organ procurements.

In the second quarter of 2022, 27% of all donor hearts transplanted in the U.S have been preserved and transported using a Paragonix SherpaPak CTS.² The Paragonix SherpaPak System is the most widely utilized FDA cleared and CE marked medical device for heart preservation and transport in the United States. Based on annual 2021 transplant data, 4 out of 5 of the largest heart transplant programs in the U.S. and 61 heart programs globally trust the Paragonix SherpaPak System to preserve, track, and transport critical donor hearts to their recipient donors.² In a recent study regarding Paragonix’s flagship advanced preservation device, the Paragonix SherpaPak Cardiac Transport System, investigators noted a one-year survival rate of 96.4% in patients where the Paragonix system was used, translating to an increase of 8.7% (p=0.03) in one-year survival when compared to traditional ice transport.¹

Combined with the LUNGguard™ Donor Lung Preservation System, Paragonix preservation devices have been used on 24% of all U.S. thoracic organ transplant cases in 2022.² As with each of the devices, temperatures are monitored throughout the organ journey via the Bluetooth^® connected Paragonix App. The LUNGguard^™ Donor Lung Preservation System provides a secure transport system that provides predictable, repeatable, and measurable results.

In January, Paragonix launched the LIVERguard™ System, providing the abdominal market with access to advanced organ preservation. Like its predecessors, the LIVERguard™ System represents a fundamental advance over the use of ice and off-the-shelf coolers that have been the standard-of-care in organ transplantation for over 50 years. Recently, Paragonix announced the Expanded Adoption of their LIVERguard™ System at the 2022 American Transplant Congress.

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References

1. Leacche et al., ISHLT Presentation 2022, Data on file
2. http://optn.transplant.hrsa.gov, Paragonix data on file

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